Using the Vibrance Kegel Device With Pelvic Floor Muscle Exercise for Stress Urinary Incontinence: A Randomized Controlled Pilot Study.

OBJECTIVE To evaluate the effectiveness of pelvic floor muscle exercises (PFMEs) performed with the new biofeedback Vibrance Kegel Device (VKD), compared to PFMEs alone, in treating stress urinary incontinence (SUI). MATERIALS AND METHODS This was a pilot prospective, randomized trial of women aged ≥18 years with SUI symptoms who underwent PFMEs at University Malaya Medical Centre from October 2011 to October 2013. The patients were randomly divided into two groups: control (PFMEs alone) and VKD (PFMEs with VKD biofeedback). The patients underwent 16 weeks of pelvic floor training, during which they were assessed using Australian pelvic floor questionnaires and modified Oxford scales for pelvic floor muscle strength at week 0, 4, and 16. RESULTS Forty patients were recruited (control 19, VKD 21). Three patients in the control group dropped out during week 16 training, whereas the VKD group had no dropouts. The VKD group reported significantly earlier improvement in SUI scores, as assessed by the Australian pelvic floor questionnaires (P = .035) at week 4. However, there was no significant difference between the groups' SUI scores at week 16. Pelvic floor muscle strength was significantly better in the VKD group at week 4 (P = .025) and week 16 (P = 0.001). The subjective cure rate was similar in both groups at week 16 (62.5% for control and 61.9% for VKD) (P = 0.742). CONCLUSION Using the VKD resulted in significant early improvement in SUI scores, and pelvic muscle strength had improved significantly by the end of the study. The VKD proved useful as an adjunct for pelvic floor training.